India and the Patent Wars

Pharmaceuticals in the New Intellectual Property Regime

Murphy Halliburton

• Publisher: ILR Press
• Year: 2017
• Print ISBN: 9781501713460
• eBook ISBN: 9781501713989
• Topic: Social Sciences
• Subtopic: Pharmaceutical, Biotechnology & Healthcare Industry
• Index: Social Sciences

India and the Patent Wars contributes to an international debate over the costs of medicine and restrictions on access under stringent patent laws showing how activists and drug companies in low-income countries seize agency and exert influence over these processes. Murphy Halliburton contributes to analyses of globalization within the fields of anthropology, sociology, law, and public health by drawing on interviews and ethnographic work with pharmaceutical producers in India and the United States.

India has been at the center of emerging controversies around patent rights related to pharmaceutical production and local medical knowledge. Halliburton shows that Big Pharma is not all-powerful, and that local activists and practitioners of ayurveda, India's largest indigenous medical system, have been able to undermine the aspirations of multinational companies and the WTO. Halliburton traces how key drug prices have gone down, not up, in low-income countries under the new patent regime through partnerships between US- and India-based companies, but warns us to be aware of access to essential medicines in low- and middle-income countries going forward.

1

THE INVENTION AND EXPANSION OF INTELLECTUAL PROPERTY

In a compelling study of our shrinking creative and cultural commons, The Public Domain (2008), the legal scholar James Boyle alerts us:

We are in the middle of a second enclosure movement. While it sounds grandiloquent to call it “the enclosure of the intangible commons of the mind,” in a very real sense that’s just what it is…. Once again things that were formerly thought of as common property, or as “uncommodifiable,” or outside the market altogether, are being covered with new, or newly extended, property rights. (45)

The first enclosure movement, which developed over the course of the fifteenth to nineteenth centuries in England, involved the privatization of what were once common lands, while this second enclosure movement involves the privatization of creative and intellectual realms through intellectual property laws. Despite sounding the alarm about the new enclosure movement, Boyle’s book opens with a defense of the basic principles of intellectual property law.

In the case of patent law, Boyle explains that this kind of protection is preferable to the previous method of gaining a commercial advantage through the maintenance of secrecy that was used, for example, by medieval guilds. The problem with secrecy is that the invention does not get broadly produced so that the greater society can enjoy its benefits, and its usefulness to society may die with the death of the innovator. Some ayurvedic doctors use this method of keeping their formulas to themselves to control the use of their innovations. Most ayurvedic practitioners I spoke to were not, however, enthusiastic about this method. They explained that they preferred that knowledge be shared, and they complained that formulations that were kept secret died with their “owners.” A patent, which is a time-limited contract between the innovator and society, and not a guarantee of enduring ownership, ensures that innovations remain as public resources after the expiration of a patent and after the death of an inventor. Boyle explains that through this contract, society is assuring innovators that if they publically disclose their invention—in enough detail so that others will be able to recreate it—the state will give them a temporary monopoly to produce the invention or transfer the rights to benefit from its production. After the term of the patent expires, the invention will become part of the public domain, available for anyone to produce. Should the inventor not wish to divulge how the invention works after the expiration of the patent or if the inventor dies, society will have an explanation of how the invention works “on file,” even though the form of the record of the patented invention has changed over time.¹

Boyle goes on to explain the other key forms of intellectual property, copyrights and trademarks that protect artistic works and symbols of trade, and then asks:

But does intellectual property work this way now, promoting the ideal of progress, a transparent marketplace, easy and cheap access to information, decentralized and iconoclastic cultural production, self-correcting innovation policy? Often it does, but distressingly often it does the reverse. The rights that were supposed to be limited in time and scope to the minimum monopoly necessary to ensure production become instead a kind of perpetual corporate welfare—restraining the next generation of creators instead of encouraging them. (8–9)

Boyle adds that through extensions of the life of copyrights to, in many cases, over a century, at least in the United States, “most of twentieth century culture is under copyright—copyrighted but unavailable. Much of this, in other words, is lost culture” (9). This is because books, films, and music are often not made available to the public because of fear of infringement.

Although the life of a copyright has been extended to over a hundred years, in most cases the life of a patent remains at twenty years. It is the enforcement of patents that has been extended, along with the application of United States–style patent law through the WTO, which includes product patents for medications and overrides much local variability in patent provisions. A key rationale of patent law, the assurance that after investing in research and bringing a new drug to market others cannot come along immediately and copy it, is now used as “a kind of blackmail” where “industry leaders and lobbyists routinely warn that lower prices will reduce funds for R&D and result in suffering and death that future medicines could reduce.”² Such appeals to the importance of recovering investments, however, obscure the significant amount of public money that goes into innovations for which corporations claim exclusive rights. Nonetheless, pharmaceutical companies have effectively mobilized the ideology of intellectual property and the threat of diminishing future drug development to advocate for the expansion of their property claims.

The Invention of Intangible Property

Anthropologists have tried to determine whether intellectual property or similar protection for intangible forms of property exists outside of European societies or before capitalism and its sanctification of private property became the global norm. Their findings have, however, been ambiguous. In 1928, Robert Lowie claimed something like intellectual property, or “incorporeal property,” to use his term, existed in precapitalist societies in the form of rights to songs and secrecy of certain kinds of knowledge. He cites, for example, research on the Eskimo, among whom “a communistic trend as to economic necessaries is coupled with strict individualism as to the magical means of securing food,” and describes the process by which ritual knowledge and songs may be “purchased” among Blackfoot Native Americans.³ A. Irving Hallowell retorted that this indicates something like mere possession, which is not equivalent to formal property rights, since such claims do not have the “commercial flavor” seen in contemporary property claims.⁴ Countering those who argue that non-Western peoples do not have principles that resemble intellectual property and believe only in communal ownership, Michael Brown offers examples of Kiowa and other Native American practices of individual ownership of songs, designs, and other forms of intangible property. He adds that “the rules controlling the flow of ideas and information are often hard to reconcile with Western practices and, perhaps more significantly, with the replicative technologies spawned by the Industrial Revolution.”⁵

It is difficult to determine whether practices such as secrecy about knowledge and “owning” songs constitute predecessors to what we know as intellectual property. If Michael Brown is right, it may be the “replicative technologies,” such as mass printing and mass manufacturing, that spur the creation of actual legal protections for intellectual property. Doctors of ayurvedic medicine speak about the maintenance of secrecy of some doctors’ formulations as if it is similar to intellectual property law. This practice may predate the commodification of medical products that developed with colonialism and capitalism, or it may be a more recent response to commodification, a defense against the practice of making and selling medical products for a profit.

The emergence of modern intellectual property law can be more distinctly defined. The granting of patents as privileges to market inventions—but not as ownership of the concept behind the invention—dates back to fifteenth-century Venice. The elements of modern patent law—which protects the information that is the basis of an invention—can be traced to transformations in claims of ownership and ideas about mental and physical labor in eighteenth-century Europe and the United States.⁶

The science historian Mario Biagioli highlights a shift that occurred around 1790, when the state stopped conceiving of patents as privileges and began protecting patents as rights. New specification requirements for patents replaced the principle that the invention was a material thing the inventor presented before representatives of the state to claim ownership. Patent laws adopted in France and the United States in the late 1700s required a precise description of the invention on paper and resulted in the protection of the idea behind the invention as property: “Allowing for the emergence of the idea as a distinct entity, specifications made possible for that idea to become the immaterial ‘essence’ of the invention.”⁷ This is the basis of the social contract behind patent law that we have today, where the state gives the innovator a temporary monopoly on his innovation in exchange for the innovator’s public disclosure of the invention in enough detail so that others can reproduce it after the patent expires or the inventor dies.

Similar principles emerged in the development of copyright law after the passage of the Statute of Anne in England in 1710. The statute claimed that “printers, booksellers, and other persons have of late frequently taken the liberty of printing, reprinting, and publishing, or causing to be printed, reprinted, and published, books and other writings, without the consent of the authors or proprietors of such books and writings, to their very great detriment, and too often to the ruin of them and their families.” “For the encouragement of learned men to compose and write useful books,” it awarded exclusive rights to print books to their authors and to those booksellers and printers to whom the authors assigned their rights.⁸ Thus the book trade’s “claims of proprietorship extended not only to the particular books they published, but to the content of those books.”⁹

Starting in the late 1700s, Wordsworth and other Romantic authors promoted the ideas that creative works came from an individual well-spring of creativity and that writers could be said to own these works. Before then:

Writers, like other artisans, considered their task to lie in the reworking of traditional materials according to principles and techniques preserved and handed down to them in rhetoric and poetics—the collective wisdom of their craft. In the event that they chanced to go beyond the state of the art, their innovation was ascribed to God, or later to Providence. Similarly, in the sphere of science, invention and discovery were viewed as essentially incremental—the inevitable outcome of a (collective) effort.¹⁰

References to the romantic myth of the individual inventor in this book thus invoke two meanings of “romantic”: it is “romantic” in the sense that it is an ideal and not a reflection of the actual practice of innovation, and it is “Romantic” in that it evokes a literary movement that inspired the idea of individual creativity in literature which is, in turn, linked to the notion of individual creativity in science.¹¹

Another important distinction emerged in copyright debates in eighteenth-century England: when “the law not only came to differentiate between mental and manual labour, it also came to privilege the labour of the mind over that of the body.”¹² The argument used by publishers was that the mental faculty is what separates man from beasts. A further hierarchy that was essential to modern intellectual property law emerged in the mid-nineteenth century, privileging mental creativity over “mere” mental labor. From the late eighteenth to early nineteenth centuries in Germany, the Republic of Letters similarly distinguished between the creative work of the intellectual and the craftwork of artisans. Artisans were denied the status of scientific authors because “they merely manipulated preexisting materials rather than creating something truly novel.”¹³ While the principles of patent law value “true innovation” over “mere manipulation,” much “innovation” in pharmacology today is achieved by “merely manipulating” preexisting innovations and concepts. Currently, the element of creativity remains enshrined in the legal requirement that an invention be original and non-obvious to obtain a patent. The US Patent Act of 1952, which in its amended form is the reigning patent law in the United States, requires that inventions be novel, non-obvious, and useful, and the patent applicant must disclose the invention in enough detail that “any person skilled in the art to which it pertains” can make it.¹⁴ Despite this seeming adherence to the standards of intellectual property law, US patent law appears very liberal in awarding patents compared to India’s 2005 Patents Act.

Intellectual property law received several boosts in the expansion of its realms of coverage and the extension of its protections in the last thirty years, especially in the United States. US intellectual property law is important for understanding the new global patent regime, since the WTO TRIPS agreement is essentially an expansion of US IP law to the rest of the world, and US interests are behind other expansions of IP law contained in bilateral agreements between nations and the proposed Trans-Pacific Partnership. In Diamond v. Chakrabarty, a landmark 1980 United States Supreme Court case that allowed the patenting of certain life forms, the microbiologist Anand Chakrabarty, working for General Electric, created a genetically modified bacterium that can be used to break up oil spills. The US Patent Commissioner challenged Chakrabarty’s attempt to patent this bacterium on the supposition that life forms cannot be patented. The case went to the Supreme Court, which decided that while existing life forms cannot be patented, this engineered organism could be because it was sufficiently altered by human intervention and was sufficiently novel.¹⁵

Also in 1980, Congress passed the Patent and Trademark Law Amendment Act—better known as the Bayh-Dole Act—which facilitated the commercialization of innovations developed at universities and nonprofit institutions. While this did not greatly increase the orientation of university research toward the production of commercial products, it continued a trend of privatizing scientific knowledge and not just the knowledge pertaining to specific inventions. In a study of patenting of university research, David Mowery and colleagues warn:

“Privatization” of knowledge inputs that formerly were part of the “scientific commons” through patenting may impede the progress of research. Increased academic patenting may also enhance incentives for faculty or universities to delay publication, restrict sharing...

Table of contents

• Acknowledgments
• Note on Names of Medications
• Introduction
• 1. The Invention and Expansion of Intellectual Property
• 2. The New Patent Regime: The Activists and Their Allies
• 3. Ayurvedic Dilemmas: Innovation, Ownership, and Resistance
• 4. The Gilead Model and the Perspective of Big Pharma
• 5. The View from Hyderabad: The “Indian” Pharmaceutical Industry and the New Patent Regime
• Conclusion
• Notes
• References
• Index